Valiant Navion™ VNMF3125C173TU (UDI 00763000100841)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000100841), received between May 9, 2023 and May 9, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Feb 12, 2021Class IOpen, Classified

   Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.

   Z-1201-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TYPE B AORTIC THORACIC DISSECTION TEVAR WAS DONE FROM ZONE II TO JUST ABOVE CELIAC AXIS. IT WAS REPORTED THE PATIENT WAS FOUND TO HAVE TYPE IB ENDOLEAK ON A CT CARRIED 10 MONTHS LATER. THE IB ENDOLEAK WAS PERSISTENT ON CT'S FROM 1 YEAR AND 5 MONTHS AND FROM 2 YEARS AND 8 MONTHS POST INDEX PROCEDURE. NO INTERVENTION WAS CARRIED OUT. THE ENDOLEAK WAS NOT VISUALIZED ON CT FROM 3 YEARS AND 5 MONTHS POST INDEX. A CT PERFORMED AT APPROXIMATELY 3 YEARS AND 9 MONTHS POST INDEX NOTED PERSISTENT TYPE IB ENDOLEAK. A CT FROM 4 WEEKS LATER NOTED STABLE FINDINGS WITH REGARDS TO ENDOVASCULAR REPAIR COMPARED TO PRIOR, BUT DID NOT SPECIFICALLY NOTE ENDOLEAK. PHYSICIAN HAS NOTED THE ENDOLEAK ON ALL PRIOR IMAGING THERE ARE NO PLANS FOR INTERVENTION/TREATMENT. THE PATIENT IS DOING WELL. NO CAUSE WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16893742 ↗